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临床试验/NCT00760903
NCT00760903撤回不适用

Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma

University of Michigan1 个研究点 分布在 1 个国家开始时间: 2003年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury.

研究概览

简要总结

The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.

By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.

Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.

By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.

Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.

详细描述

The purpose of this study is to determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. This study may show that MRI can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients of acute moderate brain trauma

排除标准

  • Patients who are medically unstable or have CT findings that may interfere with the study such as:
  • a large hemorrhage or edema
  • encephalomalacia
  • prior neurosurgeries
  • hardware placed in the head or neck
  • prior head trauma
  • history of neurological conditions

结局指标

主要结局

To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia C Maly Sundgren, MD, PhD

Principal Investigator

University of Michigan

研究点 (1)

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